Promotion of FDA-Regulated Medical Products
Table of Contents
Part I: Fundamentals
Chapter 1 Introduction to the Agencies Involved in Prescription Drug and Device Labeling
Chapter 2 Fundamental Principles for Labeling and Promotion of Prescription Medical Products
Chapter 3 Labeling and Promotion of Regulated Products Prior to Approval and Off-Label Promotion
Part II: Communications to Certain Audiences
Chapter 4 Promotion to Healthcare Professionals and Providers
Chapter 5 Direct Promotion of Prescription Products to Consumers and Patient Populations
Chapter 6 Promotion to Payers and Other Sophisticated Audiences
Part III: Practical Advice for Regulatory Professionals
Chapter 7 Additional Regulatory and Legal Considerations
Appendix 1. Selected Sections of the FD&C Act
Appendix 2. Selected FD&C Act Regulations
Appendix 3. List of Available Guidances Regarding the Labeling, Advertising and Promotion of Prescription Drugs
Joanne S. Hawana, MS, JD, Bethany J. Hills, MPH, JD and Benjamin M. Zegarelli, MS, JD
About the Book
Available formats: print and e-book
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices. Its seven chapters are divided into three parts. Part I, Fundamentals, introduces the agencies involved in prescription drug and device labeling, reviews the fundamental prescription drug and device labeling and promotion principles and labeling and promotion of these products prior to approval and for off-label use. Part II, Communications to Certain Audiences, discusses the differences in messaging for healthcare professionals, consumers and more sophisticated audiences. Part III, Practical Advice for Regulatory Professionals, examines additional promotional regulatory and legal considerations.
Who will benefit from this book?
Anyone involved in developing promotional and advertising plans for new prescription medical products would benefit from the information in this book, not just regulatory personnel, but marketing and legal teams as well as management.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2018. Paperback. 185 pages. ISBN (print): 978-1-947493-25-4. ISBN (digital): 978-1-947493-26-1.
